J&J says in talks with Indian government for trial of single-dose vaccine
Johnson & Johnson's coronavirus disease (COVID-19) vaccines are seen at Northwell Health's South Shore University Hospital in Bay Shore, New York
Johnson & Johnson is in talks withIndia's government to begin a clinical trial of its single-dose COVID-19 vaccine in the country, the company said on Friday.
The USdrugs and healthcare giant's vaccine is currently approved for use in the United States, the European Union and other nations including Thailand and South Africa.
The news comes as some parts ofIndiaface a shortage of vaccine supplies just as the country of 1.3 billion battles a second wave of COVID-19 infections.India's government, however, has said there is no shortage of shots.
J&J had sent a letter toIndia's Central Drugs Standard Control Organisation (CDSCO) saying it would "very shortly apply for permission to conduct clinical bridging trials inIndia".
"We are in discussions with the (government) with the objective of starting a bridging clinical study of our Janssen COVID-19 vaccine candidate inIndia, subject to local regulatory approvals," a local J&J representative said via email.
A bridging study tests the safety and immunogenicity of a vaccine, andIndiahas indicated that any vaccine maker must conduct such a trial for a shot to be considered for its immunisation programme.
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Separately, J&J has a deal withIndian firm Biological E Ltd to contract-manufacture its vaccine.
Indiacurrently has two approved vaccines in use, one developed by Oxford University and AstraZeneca and the other, a shot from local player Bharat Biotech.
There are other vaccine candidates in trials inIndiaincluding Russia's Sputnik-V and a shot developed by Cadila Healthcare Ltd.
COVID-19 infections inIndiarose by a record number for a third straight day on Friday, increasing by more than 130,000, while daily deaths hit their highest in five months.